MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/07/2016

Event Type  Injury  

Event Description

It was reported, through clinic notes, the patient had been referred for vns explant.It was explained the reason for the explant referral was due to the vns not being managed by any physician and the patient's voice is hoarse.Attempts for additional relevant information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

New information was received from the surgeon that only the patient's generator will be explanted.No known surgical interventions have occurred to date.

Event Description

It was reported that upon interrogation the patient's device settings were very low, and therefore her settings were adjusted and the explant surgery was cancelled.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6168598
• MDR Text Key: 62190765
• Report Number: 1644487-2016-02844
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2007
• Device Model Number: 102
• Device Lot Number: 043894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: 08/30/2017; 10/31/2017
• Supplement Dates FDA Received: 09/21/2017; 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR